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Health professionals' and researchers' opinions on conducting clinical deprescribing trials.

ABSTRACT: While clinical deprescribing trials are increasingly being performed, there is no guidance on the optimum conduction of such studies. The aim of this survey was to explore the perspectives, attitudes, interests, barriers, and enablers of conducting clinical deprescribing trials among health professionals and researchers. An anonymous survey was developed, reviewed, and piloted by all investigators and informed by consultation with experts, as well as current deprescribing guidelines. The questions were formulated around current clinical trial frameworks and incorporated identified enablers and barriers of performing deprescribing studies. The survey was sent to members of Australian and international deprescribing, pharmacological, and pharmacy organizations, and other researchers published in deprescribing. A total of 96 respondents completed the survey (92.3% completion rate). Respondents indicated the main deprescribing trial rationale is to generate evidence to optimize patient-centered outcomes (79.2%). Common barriers identified included the time and effort required (18.2%), and apprehension of health professionals involved in trials (17.1%). Studies are enabled by positive attitudes toward deprescribing of treating prescribers (24.4%) and patients (20.9%). Classical randomized controlled trials (RCTs) were deemed the most appropriate methodology (93.2%). Sixty percent of participants indicated a good clinical practice framework is required to guide the conduct of deprescribing trials. There were no significant differences in responses based on previous experience in conducting clinical deprescribing trials. In conclusion, clinical deprescribing trials should be conducted to investigate whether deprescribing medications improves patient care. A future deprescribing trial framework should use classical RCTs as a model, ensure participant safety, and target patient-centered outcomes.

SUBMITTER: Clough AJ

PROVIDER: S-EPMC6482940 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Introduction: Orthorexia nervosa (ON) is a condition that is characterized by a pathological obsession with eating foods one considers healthy and has recently been suggested as a new possible diagnosis. However, there is limited published research on health professionals' recognition, ideas and opinions regarding the diagnosis and classification of ON. Purpose: The aim of this mixed-methods study was to gain insight into the perspectives of clinically active health professionals on ON, and into their opinions on if and how the disorder should be classified. Results: Psychologists, psychiatrists, dietitians and physiotherapists in the Netherlands (n = 160) participated by responding to a self-administered questionnaire. Most health professionals (78%) reported that they thought that ON should have its own diagnosis. This opinion was more common in physical health professionals than in mental health professionals. A majority (74%) agreed that ON fits within the Diagnostic and Statistical Manual of Mental Disorders (DSM) category Eating and Feeding Disorders. Interviews with 15 mental health professionals were analyzed using code frequencies and continuous comparisons. Mental health professionals reported believing that ON is prevalent in the general population and that a separate diagnosis would have both advantages and disadvantages for health professionals and patients. Interview participants described the typical ON patient as being young, female, and highly educated; characteristics that overlap with typical anorexia nervosa and obsessive compulsive disorder cases. Conclusion: The results suggest that some health professionals from a heterogenous sample in the Netherlands think ON should have a separate diagnosis in the DSM, however, the study needs to be replicated to allow for further generalization. Methodological design of this study may be utilized in future research with similar aims. The findings can serve as a foundation for investigation of individuals' experiences of distress caused by ON, and further refinement of the diagnostic criteria.

Project description:BACKGROUND: Common mental health problems are mainly treated in primary care settings and collaboration with mental health services is needed. Prior to re-organisation of the mental health care offer in a geographical area, a study was organized: 1) to evaluate GPs' opinions on their day-to-day practice with Patients with Mental Health Problems (PMHP) and on relationships with Mental Health Professionals (MHPro); 2) to identify factors associated with perceived need for collaboration with MHPro and with actual collaboration. METHODS: All GPs in the South Yvelines area in France (n = 492) were informed of the implementation of a local mental health program. GPs interested in taking part (n = 180) were invited to complete a satisfaction questionnaire on their practice in the field of Mental Health and to include prospectively all PMHP consultants over an 8-day period (n = 1519). For each PMHP, data was collected on demographic and clinical profile, and on needs (met v. unmet) for collaboration with MHPro. RESULTS: A majority of GPs rated PMHP as requiring more care (83.4%), more time (92.3%), more frequent consultations (64.0%) and as being more difficult to refer (87.7%) than other patients. A minority of GPs had a satisfactory relationship with private psychiatrists (49.5%), public psychiatrists (35%) and social workers (27.8%). 53.9% had a less satisfactory relationship with MHPro than with other physicians. Needs for collaboration with a MHPro were more often felt in caring for PMHP who were young, not in employment, with mental health problems lasting for more than one year, with a history of psychiatric hospitalization, and showing reluctance to talk of psychological problems and to consult a MHPro. Needs for collaboration were more often met among PMHP with past psychiatric consultation or hospitalization and when the patient was not reluctant to consult a MHPro. Where needs were not met, GP would opt for the classic procedure of mental health referral for only 31.3% of their PMHP. CONCLUSION: GPs need targeted collaboration with MHPro to support their management of PMHP, whom they are willing to care for without systematic referral to specialists as the major therapeutic option.

Project description:Most tobacco-focused clinical trials are based on locally conducted studies that face significant challenges to implementation and successful execution. These challenges include the need for large, diverse, yet still representative study samples. This often means a protracted, costly, and inefficient recruitment process. Multisite clinical trials can overcome some of these hurdles but incur their own unique challenges. With recent advances in mobile health and digital technologies, there is now a promising alternative: Remote Trials. These trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, or even nation. The remote approach affords many of the benefits of multisite trials (more efficient recruitment of larger study samples) without the same barriers (cost, multisite management, and regulatory hurdles). The Coronavirus Disease 2019 (COVID-19) global health pandemic has resulted in rapid requirements to shift ongoing clinical trials to remote delivery and assessment platforms, making methods for the conduct of remote trials even more timely. The purpose of the present review is to provide an overview of available methods for the conduct of remote tobacco-focused clinical trials as well as illustrative examples of how these methods have been implemented across recently completed and ongoing tobacco studies. We focus on key aspects of the clinical trial pipeline including remote: (1) study recruitment and screening, (2) informed consent, (3) assessment, (4) biomarker collection, and (5) medication adherence monitoring. Implications With recent advances in mobile health and digital technologies, remote trials now offer a promising alternative to traditional in-person clinical trials. Remote trials afford expedient recruitment of large, demographically representative study samples, without undo burden to a research team. The present review provides an overview of available methods for the conduct of remote tobacco-focused clinical trials across key aspects of the clinical trial pipeline.

Project description:BackgroundPolypharmacy is defined as the prescription of at least 5 different medicines for therapeutic or prophylactic effect and is a serious issue among elderly patients, who are frequently affected by multi-morbidity. Deprescribing is one of the proposed approaches to reduce the number of administered drugs, by eliminating those that are inappropriately prescribed. The aim of this systematic review is to provide an updated and systematic assessment of the benefit-risk profile of deprescribing of anti-hypertensive drugs, which are among the most commonly used drugs.MethodsMEDLINE, EMBASE and The Cochrane Library were searched for studies assessing the efficacy and safety of anti-hypertensive drugs deprescribing in the period between January, 12,016 and December, 312,019. The quality of randomized clinical trials (RCTs) was assessed using the GRADE approach for the evaluation of the main outcomes. The risk of bias assessment was carried out using the Cochrane risk-of-bias tool.ResultsOverall, two RCTs were identified. Despite summarized evidence was in favor of anti-hypertensive deprescribing, the overall risk of bias was rated as high for each RCT included. According to the GRADE approach, the overall quality of the RCTs included was moderate regarding the following outcomes: systolic blood pressure < 150 mmHg after 12 weeks of follow-up, quality of life, frailty and cardiovascular risk.ConclusionsThis updated systematic review of the efficacy and safety of anti-hypertensive treatment deprescribing found two recently published RCTs, in addition to the previous guideline of the National Institute for Health and Care Excellence (NICE). Evidence points towards non-inferiority of anti-hypertensive deprescribing as compared to treatment continuation, despite the quality of published studies is not high. High quality experimental studies are urgently needed to further assess the effect of deprescribing for this drug class in specific categories of patients.

Project description:ObjectiveTo examine the determinants of deprescribing among health professionals in nursing homes, focusing on knowledge, practice and attitude.DesignThis was a qualitative study comprising semi-structured face-to-face interviews guided by 10 open-ended questions. Interviews were conducted until data saturation was achieved and no new ideas were formed. The interviews were audio-recorded, transcribed verbatim and analysed for themes. To derive themes, we employed directed content analysis of transcript data. Coding was completed using a combination of open, axial and selective coding.SettingFour nursing homes in Singapore.ParticipantsThe study involved 17 participants (comprising 4 doctors, 4 pharmacists and 9 nurses).ResultsTwo key themes were identified, enablers and challenges. These were enablers and challenges faced by doctors, pharmacists and nurses towards deprescribing. The identified subthemes for enablers of deprescribing were: (1) awareness of medications that are unnecessary or could be targeted for deprescribing; (2) improving quality of life for patients with limited life expectancy; (3) improving communication between doctors, pharmacists and nurses; (4) systematic deprescribing practice and educational tools and (5) acknowledgement of possible benefits of deprescribing. The identified subthemes for challenges of deprescribing were: (1) symptoms not acknowledged as possibly drug-related; (2) lack of knowledge in patient's and family members' preferences; (3) lack of coordination between health professionals in hospitals and nursing homes and (4) limited tools for deprescribing. The development of a local guideline, mentoring nurses, case discussions, better shared decision-making and improving multidisciplinary communication, may help to support the process of deprescribing.ConclusionIn conclusion, this study highlighted that deprescribing in the nursing homes is perceived by health professionals to be challenging and future research could assess how routine case studies, mentoring and better multidisciplinary communication could improve deprescribing knowledge and process in the nursing homes.

Project description:BackgroundThe World Health Organization (WHO) has established a set of items related to study design and administrative information that should build the minimum set of data in a study register. A more comprehensive data set for registration is currently developed by the Ottawa Group. Since nothing is known about the attitudes of academic researchers towards prospective study registration, we surveyed academic researchers about their opinion regarding the registration of study details proposed by the WHO and the Ottawa Group.MethodsThis was a web-based survey of academic researchers currently running an investigator-initiated clinical study which is registered with clinicaltrials.gov. In July 2006 we contacted 1299 principal investigators of clinical studies by e-mail explaining the purpose of the survey and a link to access a 52-item questionnaire based on the proposed minimum data set by the Ottawa Group. Two reminder e-mails were sent each two weeks apart. Association between willingness to disclose study details and study phase was assessed using the chi-squared test for trend. To explore the potential influence of non-response bias we used logistic regression to assess associations between factors associated with non-response and the willingness to register study details.ResultsOverall response was low as only 282/1299 (22%) principal investigators participated in the survey. Disclosing study documents, in particular the study protocol and financial agreements, was found to be most problematic with only 31% of respondents willing to disclose these publicly. Consequently, only 34/282 (12%) agreed to disclose all details proposed by the Ottawa Group. Logistic regression indicated no association between characteristics of non-responders and willingness to disclose details.ConclusionPrincipal investigators of non-industry sponsored studies are reluctant to disclose all data items proposed by the Ottawa Group. Disclosing the study protocol and financial agreements was found to be most problematic. Future discussions on trial registration should not only focus on industry but also on academic researchers.

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Health professionals' and researchers' opinions on conducting clinical deprescribing trials.

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